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Leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
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Identify new research opportunities beyond the OpCo or Platform core R&D efforts and support strategic IP management, as well as guidance around FDA and international regulatory matters, partnering with Platform and OpCo legal counsel.
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Represents Rocket as Subject Matter Expert on clinical data submission in meetings with FDA and other regulatory agencies; and provides leadership in addressing clinical data submission questions/comments from FDA and other regulatory agencies.
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Ensure compliance with FDA regulations, other regulatory requirements, and company policies. Support company initiatives as directed by management and in alignment with regulatory requirements.
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The Regulatory Compliance Specialist provides critical support in product management to bring new and renewal import products (mainly from South Korea) to market quickly and under compliance. Ensure FDA/USDA/CFIA labeling compliance of import product including translation and labeling information verification.
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This role’s primary responsibility is to partner with Regulatory therapy area leadership in obtaining and maintaining regulatory filings and registrations for domestic and international regions.
$180,000 - $210,000 a yearFull-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
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A) Knowledge of codes and standards relevant to safe operation of radiation producing medical devices such as National Fire Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), The Joint Commission (TJC), American College of Radiology (ACR), Center for Devices and Radiological Health (CDRH) and The Association for the Advancement of Medical Instrumentation (AAMI.
ExpandApply NowActive JobUpdated 6 days ago - UpvoteDownvoteShare Job
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Adheres to and/or is a leader in all regulatory issues (OSHA, FDA, DOT, EPA, etc. Crawling: Occasionally Ladder climbing: occasionally Repetitive Twisting Standing: Frequently Repetitive Twisting Sitting: Frequently Balance on Level Surfaces: Continuously Balance on Uneven Surfaces: Continuously Balance on Beam/Scaffold: Frequently Hand Dexterity: Continuously Finger Dexterity: Continuously.
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Owns regulatory compliance and food safety process, including proper sanitary condition, allergen control, pest control, food safety policy, employee safety policies and procedures. Operate production lines in accordance with FDA guidelines, GMPs, and HACCP/SQF program guidelines.
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Maintains functional knowledge of relevant safety codes and standards of regulatory bodies including, but not limited to, The Joint Commission (TJC), National Fire Protection Association (NFPA), Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), Association for the Advancement of Medical Instrumentation (AAMI.
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Knowledge of AABB, CAP and FDA regulatory guidelines for the Transfusion Service and Blood Center. Must be knowledgeable of AABB, CAP FDA (cGMP) and NJDOH regulatory guidelines for the Transfusion Service and Blood Center.
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Owns regulatory compliance and food safety process, including: proper sanitary condition, allergen control, pest control, food safety policy, employee safety policies and procedures, and maintaining MCRS sustainability standards.
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Act as Official Correspondent to Regulatory Authorities (e.g., FDA) on behalf of Cresilon, Inc. Submit Marketing Applications to Regulatory Authorities on behalf of Cresilon, Inc. Represent Cresilon, Inc to Regulatory Authorities, both in writing and in person.
$160,000 - $220,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Education: Minimum Bachelor's degree required with focus in the area of chemistry, biology or related science Licenses/ Certifications: Regulatory Affairs Certification (RAC Drugs) preferred Experience: At least 5 years’ pharmaceutical or biologics CMC submissions experience with FDA required.
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Interfaces directly with the FDA, EMEA, and other regulatory authorities ensuring the company is appropriately represented in communications with the health authorities. Description Reporting to the Chief Regulatory Officer, the Vice President, Quality is responsible for providing the strategic leadership and management of the company's Quality organization.
$315,000 - $320,000 a yearFull-timeExpandApply NowActive JobUpdated 3 months ago
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